Tissue marking system

ABSTRACT

A single-use tissue marking system for use in marking a tissue sample includes a container and a first number of ink reservoirs at least partially defined by the container. Each reservoir contains ink of a different color. The system also includes a second number of applicators. Each applicator is configured to absorb a quantity of ink for application to the tissue sample. A cover is coupled to and cooperates with the container to fully enclose each of the first number of ink reservoirs.

RELATED APPLICATION DATA

This application is a continuation of U.S. Ser. No. 13/838,568, filed onMar. 15, 2013; which is a continuation-in-part of U.S. patentapplication Ser. No. 11/873,249, filed Oct. 16, 2007, abandoned; whichis a continuation-in-part of U.S. patent application Ser. No.10/978,948, filed Nov. 1, 2004, abandoned; the entireties of which arefully incorporated herein by reference.

BACKGROUND OF INVENTION

The present invention relates to a tissue marking system. Moreparticularly, the present invention relates to a tissue marking systemthat includes ink.

Successful breast cancer conservation surgery requires complete removalof the cancerous tumor while preserving sufficient surrounding healthybreast tissue. The most important predictor of local cancer recurrenceis the status of the margins, the distance between the tumor and thetissue edge. Close or transected margins generally require an additionalsurgical procedure to re-excise the close or transected margin.Therefore, knowing the exact position of the close or transected marginthat requires further excision is critical, because it providesdirection from the pathology analysis to the surgeon on where cancerouscells may remain in the patient's body. In breast cancer surgery,re-excision rates run as high as 30-40%.

Currently, among many surgeons the most common method of identifying thetissue margins for pathology analysis is with sutures. However, thereare significant risks associated with using suture to orient tissue.First, suture provides ambiguous and incomplete orientation information.In other words, the original position of the specimen in the patient'sbody is unclear to the pathologist who must decide whether the marginsare sufficiently clear of cancer. In addition, the entire edge of eachof the six tissue margins is undefined; therefore the pathologist doesnot know where one margin ends and the next margin begins. The Annals ofSurgical Oncology reported a 31% error rate when sutures were used toorient excised tissue. A suture cannot represent the entire margin planeand requires the pathologist to estimate the margin boundaries. Theambiguity and incompleteness of the suture method creates the potentialfor: 1) unnecessary re-excision, or additional surgery for the patient.This brings the additional risks of a second surgery; 2) anunnecessarily large amount of tissue removed during re-excision; and 3)inaccurate re-excision which may result in cancer recurrence.

Another problem associated with using sutures is that it exposessurgeons and nurses to the risk of puncture wounds. This is asignificant problem for healthcare workers: the World HealthOrganization estimates that 9% of health care professionals willexperience percutaneous exposure to bloodborne pathogens each year; suchincidents carry the risk of contagious diseases such as Hepatitis C andHIV. Each needle injury costs the hospital approximately $3,000 intesting and treatments. The invention claimed by '249 patent increasessafety in the operating room by eliminating the risk of using suture asit applies to orienting excised tissue.

A less common alternative to using suture to orient specimens is to useink applied in the operating room by the surgeon. Use of commerciallyavailable ink to identify tissue margins can reduce re-excisions by 50%and reduce the volume of tissue removed by 73%. However, margindefinition may still be a problem because the majority of inks availableon the market today run when applied to tissue, distorting the margindefinition. This is a greater problem in areas of the specimen which areirregular (not smooth). If the ink runs into crevasses or under flaps oftissue, it may cause an unacceptable increase in false positive marginsin the pathology analysis. False positive margins can result in thepatient undergoing unnecessary surgery to re-excise tissue ormastectomy. Commercially available non-sterile inks require that thesurgeon leave the sterile field during the operation to apply ink to thespecimen. This involves an extra change of gown and gloves, which isinefficient. It also introduces an additional opportunity for error inmarking the specimen margins because the specimen is transported awayfrom the patient to another area of the operating room.

During surgery, it is often necessary to remove a sample of tissue andclosely examine that tissue sample while knowing its originalorientation within the patient. For example, cancerous tumors are oftenremoved from the patient and then examined to verify that a sufficientmargin of tissue surrounding the tumor has been removed. To determinethis, the tissue sample is examined and the margins on each surface areidentified. Should a margin be insufficient, it is important for thesurgeon to know the orientation of the sample to allow for the removalof additional tissue in the proper area.

Presently, different color sutures, different length sutures, ordifferent quantities of sutures are inserted into the tissue sample toidentify the orientation of the tissue. However, this is time consumingand the sutures can be accidentally removed making identification of thetissue orientation difficult.

What is needed is a tissue marking system that overcomes thedeficiencies of conventional marking systems.

SUMMARY OF INVENTION

The tissue marking system in accordance with the invention addresses theshortcomings of the prior art by allowing for the definition of thecomplete edge of each of the six specimen margins, which is morecomplete than a suture, because a suture marks only one point along themargin.

In one aspect of the invention, tissue marking inks are used that m moreeffectively to tissue by staying on the surface where the surgeonapplies them, thereby decreasing false positive results and unnecessarysurgeries.

In another aspect of the invention a single-use tissue marking systemfor use in marking a tissue sample is provided. The system includes acontainer and a first number of ink reservoirs at least partiallydefined by the container. Each reservoir contains ink of a differentcolor, the inks being dripless and runless on a tissue sample. Thesystem also includes a second number of applicators. Each applicator isconfigured to absorb a quantity of ink for application to the tissuesample. A cover is coupled to and cooperates with the container to fullyenclose each of the first number of ink reservoirs.

In another aspect, the invention provides a tissue marking system thatincludes a first ink reservoir containing ink of a first color, a secondink reservoir containing ink of a second color different from the firstcolor, and a first isolation space positioned between the first inkreservoir and the second ink reservoir. A third ink reservoir containsink of a third color different from the first color and the second colorand a second isolation space is positioned between the second inkreservoir and the third ink reservoir. A one piece cover is in sealablecontact with the first isolation space and the second isolation space tosealably separate the first ink reservoir, the second ink reservoir, andthe third ink reservoir. The cover is configured to be removed as onepiece to expose each of the first ink reservoir, the second inkreservoir, and the third ink reservoir.

In yet another aspect, the invention provides a tissue marking systemfor use in marking a tissue sample. The system includes a containerdefining a space and six ink reservoirs at least partially defined bythe container. Each reservoir contains ink of a different color. Sixapplicators are disposed within the space. Each applicator is configuredto absorb a quantity of ink for application to the tissue sample. Afixative is disposed within the space and a single cover is coupled tothe container to fully enclose each of the six ink reservoirs and atleast partially enclose the space.

BRIEF DESCRIPTION OF THE DRAWINGS

The description particularly refers to the accompanying figures inwhich:

FIG. 1 is a top view of a patient including a tissue sample to beremoved from the patient;

FIG. 2 is an enlarged top view of a portion of the patient and tissuesample of FIG. 1;

FIG. 3 is a side view of the portion of the patient and tissue sample ofFIG. 1;

FIG. 4 is a perspective view of the tissue sample of FIG. 1 after beingremoved from the patient of FIG. 1;

FIG. 5 is a perspective view of a tissue marking system;

FIG. 6 is a top view of another tissue marking system;

FIG. 6a is a sectional view of the tissue marking system of FIG. 6 takenalong line A-A of FIG. 6;

FIG. 7 is a sectional view of the tissue marking system of FIG. 6 takenalong line 7-7 of FIG. 6;

FIG. 8 is a perspective view of another construction of the tissuemarking system;

FIG. 9 is a perspective view of an applicator; and

FIG. 10 is a perspective view of another construction of the tissuemarking system.

Before any embodiments of the invention are explained, it is to beunderstood that the invention is not limited in its application to thedetails of construction and the arrangements of components set forth inthe following description or illustrated in the following drawings. Theinvention is capable of other embodiments and of being practiced or ofbeing carried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof is meantto encompass the items listed thereafter and equivalence thereof as wellas additional items. The terms “connected,” “coupled,” and “mounted” andvariations thereof are used broadly and encompass direct and indirectconnections, couplings, and mountings. In addition, the terms“connected” and “coupled” and variations thereof are not restricted tophysical or mechanical connections or couplings.

DETAILED DESCRIPTION OF THE DRAWINGS

With reference to FIGS. 1-3, a patient 10 and a tissue sample 15 areillustrated to show the tissue sample's orientation in the patient 10.Before proceeding, it should be noted that the present invention will bedescribed as it relates to a tissue sample 15 removed from a breast.However, one of ordinary skill in the art will realize that theinvention is applicable to many other tissue samples in whichorientation is important. For example, basal cell carcinoma alsorequires that a tissue sample be removed, and that its orientation beidentified to verify that sufficient margin has been removed. As such,the invention should not be limited only to the uses described herein asit is well suited for use with any tissue that required orientation forpathology. These tissues include but are not limited to samples ofbreast, bone, thyroid, lymph nodes, brain, sarcomas, kidney, bowel,spleen, soft tissue masses, melanoma, squamous cell skin cancer, basalcell cancer, liver tumors, and the like.

The tissue marking system in accordance with the present invention isused by surgeons and pathologists to mark cancerous tissue that isexcised from a patient during surgery. The goal of surgery is to fullyeradicate the patient's body of cancer. The single most importantpredictor of local cancer recurrence is the status of the tissuemargins, and the extent to which they are “clean” or free of cancerouscells close to the margins when analyzed in the pathology lab. Close ortransected margins generally require an additional surgical procedure tore-excise the particular margin, or there is more extensive removal oftissue, such as in a mastectomy. Therefore, knowing the exact positionof the tissue margin that requires further excision is critical, becauseit provides direction from the pathology analysis to the surgeon onwhere cancerous cells remain in the patient's body. Error in thisprocess can lead to recurrence of the cancer, which may prove fatal tothe patient. Past methods of marking the tissue to indicate how it waspositioned in the patient's body were imprecise, ambiguous, inefficient,and a source of medical error.

Referring now to the figures, FIG. 1 shows a view looking down on thepatient 10. For purposes of description, the direction 20 toward thepatient's head will be identified as superior, while the oppositedirection 25 is inferior. The direction 30 toward the patient's midlineis defined as medial, while the opposite direction 35 is defined aslateral. With reference to FIG. 3, a side view of a portion of thepatient is illustrated to further illustrate orientation. The direction40 toward the patient's exterior is defined as superficial, while theopposite direction 45 is defined as deep.

FIGS. 2 and 3 illustrate the tissue sample 15 within the patient 10prior to its removal, while FIG. 4 shows that same tissue sample 15after removal. With the sample 15 still in the patient 10, the threesurfaces 50, 55, 60 that will be marked can be seen. While any threeplanes or surfaces of the tissue sample 15 can be used to identify theorientation of the sample 15, it is preferred that at least threesubstantially orthogonal surfaces be identified, with some applicationsmarking six surfaces. In FIGS. 2 and 3, the lateral surface 50, inferiorsurface 55, and superficial surface 60 of the tissue sample 15 areshaded differently for illustrative purposes. In FIG. 4, the same threesurfaces 50, 55, 60 are shaded to indicate that they have been markedwith a different color.

Before proceeding, it should be noted that the term “ink” as used hereinis meant to encompass any coloring element that can be applied to atissue sample 15, with dye, paint, and stains being a few examples. Assuch, the invention should not be limited to ink alone.

To mark the surfaces 50, 55, 60, three different color inks areemployed. FIG. 5 illustrates a container 80 suited for use in markingthe tissue sample 15. The container 80 includes a housing 85 thatdefines three substantially separated compartments 90, 95, 100 and acover 105 pivotally attached to the housing 85. A perimeter 86 extendsaround the container 80 and encircles the three compartments 90, 95,100. Each of the three different color inks is disposed within one ofthe three compartments 90, 95, 100. The cover 105 is movable between acovering position where it covers the three compartments 90, 95, 100 andcooperates with the housing 85 to completely separate the compartments90, 95, 100, and an open position where the ink is accessible.

Each compartment 90, 95, 100 includes a bottom surface and a wall thatsurrounds the bottom surface. Opposite the bottom surface is an openingthat allows for access to the ink during use.

In some constructions, each of the inks is simply disposed within one ofthe compartments 90, 95, 100. Generally, the ink in the compartments isin liquid form. In other constructions, an ink absorbent material 110,such as foam or felt, is disposed within each compartment 90, 95, 100and is operable to absorb and hold the ink to inhibit spillage andmixing between the ink compartments 90, 95, 100.

Each quantity of ink is a different color than the remaining twoquantities of ink. Thus, the first quantity of ink may be yellow, thesecond quantity of ink may be red, and the third quantity of ink may beblack. Of course different colors (e.g., black, blue, green, red,yellow, orange, violet, and the like) could also be employed if desired.In addition, different colors may be employed depending on theparticular tissue sample 15 to be removed. For example, breast tissuemay be better examined if yellow, red, and blue inks are used, whilebasal cell samples may be better examined using red, blue, and blackink. Thus, the actual colors employed may be varied greatly.

Generally, the container 80 is a single use tool that is used during asurgical procedure or a series of surgical procedures performed duringthe course of a day. Thus, the container 80 and its contents aresterilized. While many different sterilization procedures are possible,it is believed that gamma ray sterilization is best suited to the taskof sterilizing the container 80 and its contents with othersterilization processes also being possible. In some constructions, aforceps 115 or tweezers is attached to the cover 105 and can be removedfor use in grasping and marking the tissue sample 15. Thus, the tissuesample 15 can be marked using the enclosed forceps 115 and the forceps115 and the container 80 can be discarded after use.

While many different manufacturing processes are possible it ispreferred that the container 80, including the cover 105, be injectionmolded as a single component. In constructions that are molded as asingle component, a living hinge 118 would generally be employed betweenthe cover 105 and the housing 85. Of course, other manufacturing methodsand other connections between the cover 105 and housing 85 could beemployed if desired. FIG. 6 illustrates another container 120 thatsupports three ink reservoirs 125, 126, 127 and is suited for use inmarking the tissue sample 15. Like the container 80, the container 120is a single use tool that is used during a surgical procedure or aseries of surgical procedures throughout a day. For example, onecontainer could be opened during a first surgical procedure and could beused throughout the day for a series of procedures before beingdiscarded. In preferred constructions, the container 120 and itscontents are sterilized before they are opened. The container 120includes a formed portion 130 that defines the three ink reservoirs 125,126, 127. The reservoirs 125, 126, 127 are slight depressions in theformed portion 130 that are sized to contain a quantity of ink. A firstisolation space 140 is formed between the first reservoir 125 and thesecond reservoir 126 and a second isolation space 145 is formed betweenthe second reservoir 126 and the third reservoir 127. The formed portion130 also defines a perimeter 150 that surrounds the three reservoirs125, 126, 127. In most constructions, the perimeter 150, the firstisolation space 140, and the second isolation space 145 are allsubstantially disposed within a single plane and the reservoirs 125,126, 127 extend below that plane.

In some constructions, a ridge 155 (shown in FIG. 6a ) is formed aroundthe perimeter 150 to increase the stiffness of the formed portion 130.The ridge 155 may have a semi-circular, square, triangular, polygonal,or any other suitable cross-section. Generally, the ridge 155 extendsdownward below the perimeter to provide the additional stiffness. Theridge 155 also reduces the likelihood of tearing a surgical glove byreducing the number of sharp edges. The increased stiffness that resultsfrom the ridge 155 allows the container 120 to be used without beingcompletely supported from beneath the reservoirs 125, 126, 127.

The ink, dye, or other marking substance is disposed within each of thereservoirs 125, 126, 127. As discussed with regard to FIG. 5, an inkabsorbing material 160 such as felt or foam, can be placed within eachof the reservoirs 125, 126, 127 to hold the ink and reduce thelikelihood of spillage and mixing.

A cover 165 extends over the top of the open reservoirs 125, 126, 127and sealably engages the perimeter 150, the first isolation space 140,and the second isolation space 145. The cover 165 inhibits spillage,mixing, drying, and contamination of the ink before and aftersterilization. In most constructions, the cover 165 is a thin plasticfilm or a thin foil that is adhesively bonded, heat sealed, or otherwiseattached to the formed portion 130. In adhesively bonded constructions,an adhesive is applied to the one or both of the cover 165 and theformed portion 130 in, or adjacent to, the perimeter 150, the firstisolation space 140, and the second isolation space 145 such that whenthe cover 165 is positioned as desired, the cover 165 adhesively bondsto the formed portion 130. Once sealed by the cover 165, the container120 and the ink can be sterilized, transported, and stored for futureuse.

It should be noted that the thin plastic cover 165 could be used withthe construction of FIG. 5 in place of, or in conjunction with, thecover 105.

To manufacture the container 120, the formed portion 130 is firststamped or injection molded from a thermoplastic material. Of courseother materials (e.g., metals, composites, and the like) and othermanufacturing processes could be used if desired. The ink holdingcomponent 160 (e.g., felt, foam, etc.) is positioned within each of thereservoirs 125, 126, 127 if employed. The different color inks are thenplaced in the individual reservoirs 125, 126, 127. Adhesive is appliedto one, or both, of the cover 165 and the formed portion 130 and thecover 165 is positioned on the formed portion 130 to complete theassembly of the container 120. The container 120 is then sterilized andpackaged for use at a future date.

FIG. 7 is a sectional view taken along the longitudinal axis of thecontainer 120 of FIG. 6. As can be seen, the perimeter 150 the firstisolation space 140 and the second isolation space 145 reside in asingle plane that allows the cover to sealably engage the container andseal each reservoir from the other reservoirs. The ridge 155 extendsdownward to increase the stiffness of the container 120 and to eliminatea thin edge that would otherwise exist and would provide a sharp surfacethat could tear a surgical glove.

In use, the constructions of FIG. 5 and FIGS. 6, 6 a, and 7 functionsimilarly. The cover 105, 165 is first opened or removed to expose theink. A first surface 50 of the tissue sample 15 is dipped into the firstreservoir 90, 125, a second surface 55 of the tissue sample 15 is dippedinto the second reservoir 95, 126, and a third surface 60 of the tissuesample 15 is dipped into the third reservoir 100, 127. In mostconstructions, quick-drying ink is used to further speed the process.Generally, quick-drying ink is ink that dries in less than about 15minutes with inks that dry in less than 5 minutes being preferred. Oncethe three surfaces 50, 55, 60 are marked, the orientation of the tissuesample 15 is easily identified and someone other than the surgeon canexamine the sample while accurately understanding the originalorientation of the tissue within the patient's body.

In some constructions, a label 175 is provided with the container 120 asshown in FIGS. 5 and 6. The label 175 is pre-marked with the ink colorsand a space. The nurse or surgeon can identify the surface marked witheach color ink by identifying that surface in the space adjacent thecorrect color on the preprinted label. The label 175 is then pealed offand affixed to the tissue sample 15 or the container that contains thetissue sample 15. In still other constructions, preprinted labelsinclude the colors and a preprinted surface identification, therebyeliminating the need to write the orientation on the label. In addition,some constructions include duplicate labels to allow for easyidentification on a patient's chart.

It should be noted that all of the constructions illustrated anddiscussed herein could also include a stick surface 180 (shown in FIGS.6a and 7). The stick surface reduces the likelihood of the containerslipping off of a surface when the container 80, 120 is positioned foruse. As such, the stick surface 180 is generally positioned opposite areservoir opening, as illustrated in FIGS. 6a and 7. Many substances(e.g., rubber, VELCRO, adhesives, and the like) can be used as a sticksurface 180.

FIG. 8 illustrates another construction of a single-use tissue markingsystem 500 that includes a container 505 preferably formed from as asingle unitary piece using a thermoplastic material. The container 505defines three reservoirs 510 sized to contain a quantity of ink or die.The container 505 includes another compartment or space 515 sized toreceive a container of fixative 520. The fixative 520 can be applied tothe tissue sample before or after the ink or die is applied to improvethe adhesion of the ink or die and inhibit running and drops. Onefixative 520 suitable for use includes vinegar or a vinegar solution,with other fixatives 520 also being possible depending on the type ofink or die employed. In preferred constructions the fixative 520 iscontained in a bottle with a spray nozzle 525. The spray nozzle 525assures that a fine mist of fixative is sprayed onto the tissue ratherthan large droplets.

The container 505 defines an elongated space 530 that is sized toreceive a plurality of applicators 535. In preferred constructions, thequantity of applicators 535 equals the quantity of ink reservoirs 505.As such, the illustrated construction includes three ink reservoirs 505and three applicators 535. However, other constructions may include adifferent number of applicators 535 than reservoirs 505. For example,one construction could include six ink reservoirs 505 and threeapplicators 535. As one of ordinary skill will realize, many differentquantities of applicators 535 and reservoirs 505 can be employed. Forexample, some constructions may include six ink reservoirs 505 and sixapplicators 535.

In the illustrated construction, the elongated space 530 includes aplurality of separator elements 540 that support and separate theapplicators 535 within the space 530. The positioning within the space530 allows a surgeon or other user to easily remove the applicators 535with a gloved hand and with little risk of tearing or puncturing theglove.

Each applicator 535 includes a handle portion 545 and a sponge portion550. In preferred constructions, the handle portion 545 is formed from aplastic material. The sponge portion 550 is sized to absorb and hold adesired quantity of ink, while facilitating the accurate placement ofthe ink on the tissue sample. By depressing the sponge 550 onto thetissue sample, the surgeon is able to release a desired quantity of inkwithout causing drips or runs that can blur or confuse the marking.

The following table sets forth the desired viscosities for exemplaryinks used in the present invention, which provide the unexpected resultof being dripless and runless on the tissue sample that can blur orconfuse the marking and the misidentification of the tissue margin.

Type C rethdosics Type X1 Xantham VISCOSITY VISCOSITY VISCOSITYPERFORMANCE Krebs Units Krebs Units BAND Red 95 ku-110 ku 90 ku-105 ku85 ku-115 ku Blue 95 ku-110 ku 90 ku-105 ku 85 ku-115 ku Green 95 ku-110ku 90 ku-105 ku 85 ku-115 ku Yellow 95 ku-110 ku 90 ku-105 ku 85 ku-115ku Orange 95 ku-110 ku 90 ku-105 ku 85 ku-115 ku Black 95 ku-110 ku 90ku-105 ku 85 ku-115 ku Violet 95 ku-110 ku 90 ku-105 ku 85 ku-115 ku

The novel inks that are used in the present invention having theaforementioned unique viscosities are prepared by one of the twofollowing methods:

Colorants used in the inks in accordance with the invention include thefollowing.

-   -   Titanium White—UCD 1106E color index Wh 6    -   Lampblack—UCD 1625E color index Bk 7    -   Phthalo Blue—UCD 4830E color index Bl 15:2    -   Phthalo Green—UCD 5150E color index G 7    -   Diarylide Yellow—UCD 5675E color index Y 14    -   Organic Orange—UCD 6012E color index Or 34    -   Organic Red—UCD 7949E color index R 170    -   Carbozole Violet—UCD 8406E color index V 23 (Barney Purple)

Method I

Solution A is prepared as follows:

Solution A Deionized Water 389 grams Methyl ethyl hydroxyethyl cellulose 10 grams Arnino-2-inethyl-l-propanol 95% active  1 gram (5% water)

Three hundred eight nine grams of deionized water is added to a mixingvessel.

Ten grams of methyl ethyl hydroxyethyl cellulose is then added to thewater under agitation until smooth. One gram ofamino-2-methyl-1-propanol (95% active) is added to the solution and thesolution is allowed to mix overnight for about 10 hours. The resultingsolution is clear, lump-free and gel-like.

Using Solution A and the above-referenced colorants the inks used in thetissue marking system in accordance with the invention are prepared asfollows:

Color Base A Alkali soluble styrene acrylic resin 100 grams Solution A 80 grams Desired Colarant  84 grams

One hundred grams of alkali soluble styrene acrylic resin is added toeighty grams of Solution A in a mixing vessel. The mixture is mixed witha dispersion blade until smooth and lump free. Eighty-four grams of thedesired colorant is added under agitation and mixed for 10-15 minutes.The resulting viscosity of the ink is between 5,000-10,000 cps dependingon the colorant used.

Method II

A second method of preparing the inks having the desired viscosity usedwith the tissue marking system in accordance with the invention is asfollows:

Solution B Isopropyl Alcohol  62 grams Xanthan Gum  8 grams DeionizedWater 300 grams

Sixty-two grams of isopropyl alcohol is added to a mixing vessel. Eightgrams of xanthan gum is added to the isopropyl alcohol and mixed with adispersion blade at low speed until lump free. Three hundred grams ofdeionized water is slowly added to the mixture until it begins tothicken. The speed of the dispersion blade is increased and then theremained of the water is added to form a substantially solid gel. Thegel is allowed to stand overnight before using.

COLORANT BASE B Alkali soluble styrene acrylic resin  100 grams SolutionB   80 grams Desired Colorant   84 grams Xanthan Gum  1.5 grams

One hundred grams of Alkali soluble styrene acrylic resin is added toeighty grams of Solution B in a mixing vessel and mixed with adispersion blade until smooth and lump free. Eighty four grams of thedesired colorant is added under agitation and mixed for 10-15 minutes.One and one-half grams of xanthan gum is added under vigorous agitationby vortex for 15-20 minutes. The resulting viscosity is 8,000-10,000 cpsdepending upon the desired colorant used.

The inks are added to the reservoirs and a removable cover member (notshown) similar to that illustrated in FIGS. 6, 6 a, and 7 is employed tocover the container 505. The cover adhesively bonds to the container 505and seals each ink and each ink reservoir 510 from the other inkreservoirs, the fixative space 515, and the elongated space 530 toinhibit leakage of the inks. In preferred constructions, a singleone-piece cover is employed to expedite the opening of the inkreservoirs 510 and other spaces 515, 530.

As with the prior embodiments, the container 505 is a single-use devicethat is preferably sterilized prior to use. The user or surgeon grasps ahandle 555 and removes the cover from the container 505 to completelyexpose each of the inks for use. Each applicator 535 is used with one ofthe inks to apply the ink to the tissue sample. The fixative 520 isapplied before or after the ink is applied to assure that the inkremains fixed to the tissue sample. Once the tissue sample is properlymarked, the container 505, cover, and applicators 535 can be discarded.

As noted, other constructions of the applicator are also possible. Asillustrated in FIG. 9, one construction of an applicator 600 includes ahandle portion 605, a first sponge portion 610, and a second spongeportion 615. The first sponge portion 610 is similar to the spongeportion 550. The second sponge portion 615 includes a sponge or othermaterial that will hold a quantity of ink. However, the second spongeportion 615 includes a small edge that allows for the finer moreaccurate placement of ink should it be necessary.

As was also noted, other constructions may employ more reservoirs tohold more colors of ink and may include more applicators. For example,FIG. 10 illustrates a construction that includes a housing 900 thatdefines six reservoirs 905 that can be filled with six different colorsof ink or dye as desired. In some cases, six different color inks arepreferred to allow the surgeon to identify all six sides of the tissuesample. Alternatively, preferred colors can be used depending on thetype of tissue or tumor.

Each reservoir 905 is surrounded by a ridge 906 that engages a cover(not shown) to assure that when the cover is in place, each reservoir905 is sealed to inhibit leakage of ink from the reservoir 905.

In some constructions, each of the reservoirs 905 is labeled to aid thesurgeon in properly marking the tissue sample. For example, oneconstruction includes one of anterior, posterior, superior, inferior,medial, or lateral adjacent each of the reservoirs 905. Of course otherlabels could be employed if desired.

The construction of FIG. 10 also includes a bottle of fixative 910 andsix applicators 915 rather than the three illustrated in FIG. 8. Eachapplicator 915 would typically be used with only one color ink toinhibit mixing of colors. While the illustrated applicators 915 includea single sponge end 920, other constructions could employ the applicator600 illustrated in FIG. 9 if desired.

As with prior constructions, the housing 900 is covered with a singlecover (not shown) that seals each of the reservoirs 905 and is removableto expose each of the six reservoirs 905, applicators 915, and fixative910 for use. Once the cover is removed, the product is used for one ormore surgical procedures and then is discarded. Thus, the constructionof FIG. 10 is a single-use device.

Although the invention has been described in detail with reference tocertain preferred embodiments, variations and modifications exist withinthe scope and spirit of the invention as described and defined in thefollowing claims.

We claim:
 1. A single patient use tissue marking system for use inmarking a tissue sample having first, second and third adjacent surfaceseach defined by a tissue margin, the system comprising: a container; aplurality of inks each of a different color, each of said inksconsisting essentially of a composition including water, a colorant,methyl ethyl hydroxyethyl cellulose, a preservative, and an alkalisoluble acrylic resin, said inks having a viscosity of from 85 ku to 115ku, which when applied to one of said first, second or third adjacenttissue surfaces adheres to said surfaces without migrating onto anadjacent tissue surface; a plurality of ink reservoirs at leastpartially defined by said container, each of said plurality of inkreservoirs containing solely one of said plurality of ready to use inks;a plurality of applicators, each of said plurality of applicatorsconfigured to absorb a quantity of one of said plurality of ready to useinks for application to at least one of said three adjacent surfaces ofthe tissue sample; and a removable cover coupled to and cooperating withthe container to fully enclose each of the plurality of ink reservoirssuch that when removed the tissue marking system is for a one-time use.2. The single patient use tissue marking system of claim 1, wherein theplurality of ready to use inks and the plurality of applicators areequal in number.
 3. The single patient use tissue marking system ofclaim 2, wherein the plurality of ready to use inks is three.
 4. Thesingle patient use tissue marking system of claim 1, further comprisinga fixative disposed within the container.
 5. The single patient usetissue marking system of claim 4, wherein the fixative is containedwithin a bottle having a spray nozzle, the bottle disposed within thecontainer.
 6. The single patient use tissue marking system of claim 1,wherein each of the plurality of applicators includes a handle portionand a first sponge portion.
 7. The single patient use tissue markingsystem of claim 6, wherein each of the plurality of applicators includesa second sponge portion that is smaller than the first sponge portion.8. A single patient use tissue marking system for use in marking atissue sample having at least three adjacent tissue surfaces, said atleast three adjacent tissue surfaces being bounded by a tissue margin,the system comprising: a sterile container configured for introductioninto a surgical operating area for a one time use; a plurality ofdifferent colored ready to use sterile inks, each of said ready to usesterile inks consisting essentially of a composition including water, acolorant, methyl ethyl hydroxyethyl cellulose, a preservative, and analkali soluble acrylic resin, said sterile inks having a viscosity offrom 85 ku to 115 ku such that said sterile ink remains on at least oneof said three tissue surfaces without migrating onto an adjacent tissuesurface when applied to said at least one of said three tissue surfaces;a plurality of ink reservoirs, each of said plurality of ink reservoirsconfigured to solely contain one of said plurality of different coloredready to use sterile inks; a plurality of applicators, each applicatorconfigured to absorb a quantity of one of said inks for application ontoone surface of the tissue sample; and a removable cover coupled to andcooperating with the container to fully enclose each of the first numberof ink reservoirs such that when the cover is removed the tissue markingsystem is for a one-time use.